Blake Medical Center is proud to announce that the Florida Committee for Employer Support of the Guard and Reserve (ESGR), an agency of the Department of Defense, announced today that Jody Nader, Nursing...

Dotarem Approved for Nervous System MRIs

THURSDAY, March 21, 2013 (HealthDay News) -- Dotarem (gadoterate meglumine) has been approved by the U.S. Food and Drug Administration as a contrast agent for use in MRIs of the brain, spine and other parts of the central nervous system.

Approved for people two years and older, the imaging agent helps radiologists detect lesions and other abnormalities. Dotarem and similar agents all carry a boxed label warning of the risk of nephrogenic systemic fibrosis, a rare yet dangerous condition that can develop in people with kidney disease, the FDA said in a news release. The condition is characterized by pain and thickening of the skin.

Dotarem's safety and effectiveness were evaluated in clinical studies involving 245 adults and 38 children with suspected abnormalities of the central nervous system. All side effects were rare, the agency said, but the most common ones included nausea, headache, a burning sensation, and injection-site pain and coldness.

Dotarem is marketed by Guerbet LLC, based in Bloomington, Ind.

More information

The FDA has more about this approval (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm344758.htm ).

-- Scott Roberts

This content is reviewed regularly and is updated when new and relevant evidence is made available. This information is neither intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with questions regarding a medical condition.